NCT06627556

A Study of Single and Multiple Ascending Doses of H021 in Healthy Participants

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of H021 in Healthy Participants

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Jiangsu Carephar Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The primary purpose of this study is to evaluate the safety and tolerability of H021 tablets following oral administration of single and multiple ascending doses in healthy participants.

Detailed description

This is a single center, Phase 1, randomized, double-blind, placebo controlled, sequential single ascending dose/multiple ascending dose (SAD/MAD) study, with a food-effect arm. The study will be divided into two parts: * SAD cohorts, with food-effect evaluation * MAD cohorts The two parts will be completed sequentially but with partial overlapping. The MAD phase can start once safety, tolerability, and pharmacokinetic data from the SAD phase show that single doses of at least 25 mg are acceptable. If the 25 mg dose will be not reached in the SAD phase, the Safety Review Committee (SRC) will set a new starting dose.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	H021	H021 oral tablet.
DRUG	H021 Placebo	H021 placebo oral tablet.

Timeline

• Start date: 2024-09-17
• Primary completion: 2025-02-27
• Completion: 2025-02-27
• First posted: 2024-10-04
• Last updated: 2024-10-04

Locations

1 site across 1 country: Australia